New Indications and Dosage Forms for 2018

January 5, 2018

• FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma

January 11, 2018

• GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older

January 12, 2018

• FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer

January 16, 2018

• FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

January 25, 2018

• Synergy Pharmaceuticals Announces FDA Approval of Trulance (plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults

February 1, 2018

• FDA Approves Avycaz (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

February 5, 2018

• AMAG Pharmaceuticals Announces FDA Approval of Feraheme (ferumoxytol injection) for All Eligible Adult Patients with Iron Deficiency Anemia

February 8, 2018

• Zytiga (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

February 14, 2018

• AMAG Pharmaceuticals Announces FDA Approval of Makena (hydroxyprogesterone caproate injection) Subcutaneous Auto-Injector to Reduce the Risk of Preterm Birth in Certain At-Risk Women

February 16, 2018

• FDA Approves Imfinzi (durvalumab) for Unresectable Stage III Non-Small Cell Lung Cancer

February 22, 2018

• FDA Approves Expanded Use of Luzu (luliconazole) Cream in Pediatric Patients with Athlete’s Foot, Jock Itch and Ringworm

February 26, 2018

• Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer

March 2, 2018

• Otonomy Announces FDA Approval of Otiprio (ciprofloxacin otic suspension) for Acute Otitis Externa

March 6, 2018

• Bristol-Myers Squibb’s Opdivo (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing
• FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)

March 16, 2018

• FDA Approves Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

March 20, 2018

• FDA Expands Approval of Adcetris (brentuximab vedotin) for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination with Chemotherapy

March 21, 2018

• FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy

March 22, 2018

• Novartis Drug Tasigna Approved by FDA to Treat Children with Rare Form of Leukemia

March 27, 2018

• FDA Approves Toujeo (insulin glargine) Max SoloStar

March 29, 2018

• FDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

April 3, 2018

• FDA Approves Bydureon (exenatide extended-release) for Use with Basal Insulin in Patients with Type 2 Diabetes with Inadequate Glycemic Control

April 6, 2018

• Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
• Pacira Announces FDA Approval of Exparel as a Nerve Block to Produce Regional Analgesia

April 12, 2018

• FDA Approves Afinitor Disperz (everolimus) for Tuberous Sclerosis Complex-Associated Partial-Onset Seizures

April 16, 2018

• FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

April 17, 2018

• FDA Approves Vonvendi [von Willebrand factor (recombinant)] for Perioperative Management of Bleeding in Adult Patients with von Willebrand Disease
• FDA Provides Full Approval to Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa

April 18, 2018

• FDA Approves Tagrisso (osimertinib) as First-Line Treatment for EGFR-Mutated Non-Small Cell Lung Cancer

April 30, 2018

• Novartis Receives FDA Approval of Tafinlar + Mekinist for Adjuvant Treatment of BRAF V600-Mutant Melanoma

May 1, 2018

• Kymriah (tisagenlecleucel) Receives Second FDA Approval to Treat Appropriate Patients with Large B-Cell Lymphoma

May 4, 2018

• FDA Approves Tafinlar + Mekinist for the Treatment of BRAF-Positive Anaplastic Thyroid Cancer

May 7, 2018

• FDA Approves Darzalex (daratumumab) for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible
• FDA Approves Supplemental New Drug Application for Myrbetriq (mirabegron) for Use in Combination with Solifenacin Succinate for the Treatment of Overactive Bladder Symptoms

May 11, 2018

• FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients

May 14, 2018

• FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis
• UCB Announces Briviact (brivaracetam) Now Approved by FDA to Treat Partial-Onset (Focal) Seizures in Pediatric Epilepsy Patients

May 15, 2018

• FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents

May 21, 2018

• FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis

May 22, 2018

• Lilly's Taltz (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area

May 24, 2018

• GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age

May 28, 2018

• UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis

May 30, 2018

• Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis

June 7, 2018

• FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
• FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris

June 8, 2018

• Genentech Announces FDA Approval for Venclexta Plus Rituxan for People With Previously Treated Chronic Lymphocytic Leukemia

June 12, 2018

• FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1

June 13, 2018

• FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
• FDA Approves Genentech’s Avastin (bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery

June 21, 2018

• Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients

June 29, 2018

• Acadia Pharmaceuticals Announces FDA Approval of New Dosing Formulation and Strength for Nuplazid (pimavanserin)

July 2, 2018

• FDA Approves Aristada Initio (aripiprazole lauroxil) for the Initiation of Aristada for Schizophrenia

July 3, 2018

• FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)

July 11, 2018

• Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Combination Approved for Previously Treated MSI-H/dMMR Metastatic Colorectal Cancer

July 13, 2018

• FDA Approves Xtandi (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

July 18, 2018

• Kisqali (ribociclib) Approved for Additional Indications in HR+/HER2- Advanced Breast Cancer

July 31, 2018

• United Therapeutics Announces FDA Approval of the Implantable System for Remodulin

August 6, 2018

• Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States

August 7, 2018

• FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years

August 15, 2018

• FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

August 16, 2018

• FDA Approves Lenvima (lenvatinib) for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)

August 17, 2018

• FDA Approves Opdivo (nivolumab) for Certain Patients with Previously Treated Small Cell Lung Cancer
• FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration

August 21, 2018

• FDA Approves Expanded Label for Merck’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations

August 27, 2018

• FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia

September 13, 2018

• FDA Approves Subcutaneous Formulation of Actemra for Use in Active Systemic Juvenile Idiopathic Arthritis (SJIA)

September 27, 2018

• Adamis Pharmaceuticals Receives FDA Approval for Its Lower Dose Symjepi Product

September 28, 2018

• FDA Approves Fycompa for the Treatment of Partial-Onset Seizures in Pediatric Patients as Young as 4 Years Old
• FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation

October 1, 2018

• FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma

October 4, 2018

• FDA Approves Genentech’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors

October 5, 2018

• FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
• FDA Approves Accelerated 7-Day Vaccine Dosing Schedule for Ixiaro

October 11, 2018

• FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)

October 16, 2018

• FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Five Years

October 19, 2018

• FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma

October 23, 2018

• Seqirus Receives FDA Approval of Afluria and Afluria Quadrivalent (Influenza Vaccine) for People Six Months of Age and Older in the U.S.

October 30, 2018

• FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
• FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

November 6, 2018

• FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

November 9, 2018

• FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib

November 16, 2018

• FDA Approves Promacta (eltrombopag) for First-Line Severe Aplastic Anemia
• FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas

November 21, 2018

• Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy

November 26, 2018

• FDA Approves The ACTpen for Actemra, A Single-Dose, Prefilled Autoinjector

December 6, 2018

• FDA Approves Genentech’s Tecentriq in Combination With Avastin and Chemotherapy for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

December 14, 2018

• FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia

December 19, 2018

• FDA Approves New Indication for Envarsus XR (tacrolimus extended-release tablets)
• Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
• FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma

December 27, 2018

• Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns